Multiple Sclerosis Clinical Trial

A Survey to Evaluate Early Experience From Patient and Care Partner on Injection and Device for KESIMPTA® Indicated for Multiple Sclerosis

Summary

This is a US-based, observational cross-sectional study with primary data collection via questionnaires directly administered to patients with MS receiving KESIMPTA and care partners of patients with MS (formal or informal)receiving KESIMPTA.

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Full Description

The study aimed to enroll ninety-four (94) patients/care partners. The time period for enrollment was dependent on the uptake of KESIMPTA in the real-world.

Data collected for the study was obtained directly from the patient/care partner within the web-based database: De-identified data was stored on a secure server and transferred for analysis. Responses from the patient and care partner surveys were pooled for analysis of study endpoints.

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Eligibility Criteria

Patients with MS Inclusion Criteria:

Adult aged eighteen (18) years of age or over at the time of the survey
Prescribed KESIMPTA within the prior 12 months and currently self-administering treatment using the Sensoready® pen
MS diagnosis based on 2017 McDonald criteria

Care Partner Inclusion Criteria:

Adult aged eighteen (18) years of age or over
Formal or informal care partner of patient with MS prescribed KESIMPTA within the prior 12 months
Is currently administering KESIMPTA using the Sensoready® pen on their patient's behalf

Patients with MS Exclusion Criteria:

Previously used injection as a part of inclusion in any ofatumumab (OMB) randomized clinical trial
Active Hepatitis B virus (HBV)
Cognitive impairment that would impact their ability to participate in a survey study

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

105

Study ID:

NCT05334472

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There is 1 Location for this study

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Novartis Investigative Site
East Hanover New Jersey, 07936, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

105

Study ID:

NCT05334472

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

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